16
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      The impact of community-based integrated HIV and sexual and reproductive health services for youth on population-level HIV viral load and sexually transmitted infections in Zimbabwe: protocol for the CHIEDZA cluster-randomised trial

      other

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Background

          Youth have poorer HIV-related outcomes when compared to other age-groups. We describe the protocol for a cluster randomised trial (CRT) to evaluate the effectiveness of community-based, integrated HIV and sexual and reproductive health services for youth on HIV outcomes.

          Protocol

          The CHIEDZA trial is being conducted in three provinces in Zimbabwe, each with eight geographically demarcated areas (clusters) (total 24 clusters) randomised 1:1 to standard of care (existing health services) or to the intervention. The intervention comprises community-based delivery of HIV services including testing, antiretroviral therapy, treatment monitoring and adherence support as well as family planning, syndromic management of sexually transmitted infections (STIs), menstrual health management, condoms and HIV prevention and general health counselling. Youth aged 16–24 years living within intervention clusters are eligible to access CHIEDZA services. A CRT of STI screening (chlamydia, gonorrhoea and trichomoniasis) is nested in two provinces (16 of 24 clusters). The intervention is delivered over a 30-month period by a multidisciplinary team trained and configured to provide high-quality, youth friendly services.

          Outcomes will be ascertained through a population-based survey of 18–24-year-olds. The primary outcome is HIV viral load <1000 copies/ml in those living with HIV and proportion who test positive for STIs (for the nested trial). A detailed process and cost evaluation of the trial will be conducted.

          Ethics and Dissemination

          The trial protocol was approved by the Medical Research Council of Zimbabwe, the Biomedical Research and Training Institute Institutional Review Board and the London School of Hygiene & Tropical Medicine Research Ethics Committee. Results will be submitted to open-access peer-reviewed journals, presented at academic meetings and shared with participating communities and with national and international policy-making bodies.

          Trial Registration

          https://clinicaltrials.gov/: NCT03719521

          Related collections

          Most cited references42

          • Record: found
          • Abstract: found
          • Article: found
          Is Open Access

          Process evaluation of complex interventions: Medical Research Council guidance

          Process evaluation is an essential part of designing and testing complex interventions. New MRC guidance provides a framework for conducting and reporting process evaluation studies
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Prevention of HIV-1 infection with early antiretroviral therapy.

            Antiretroviral therapy that reduces viral replication could limit the transmission of human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. In nine countries, we enrolled 1763 couples in which one partner was HIV-1-positive and the other was HIV-1-negative; 54% of the subjects were from Africa, and 50% of infected partners were men. HIV-1-infected subjects with CD4 counts between 350 and 550 cells per cubic millimeter were randomly assigned in a 1:1 ratio to receive antiretroviral therapy either immediately (early therapy) or after a decline in the CD4 count or the onset of HIV-1-related symptoms (delayed therapy). The primary prevention end point was linked HIV-1 transmission in HIV-1-negative partners. The primary clinical end point was the earliest occurrence of pulmonary tuberculosis, severe bacterial infection, a World Health Organization stage 4 event, or death. As of February 21, 2011, a total of 39 HIV-1 transmissions were observed (incidence rate, 1.2 per 100 person-years; 95% confidence interval [CI], 0.9 to 1.7); of these, 28 were virologically linked to the infected partner (incidence rate, 0.9 per 100 person-years, 95% CI, 0.6 to 1.3). Of the 28 linked transmissions, only 1 occurred in the early-therapy group (hazard ratio, 0.04; 95% CI, 0.01 to 0.27; P<0.001). Subjects receiving early therapy had fewer treatment end points (hazard ratio, 0.59; 95% CI, 0.40 to 0.88; P=0.01). The early initiation of antiretroviral therapy reduced rates of sexual transmission of HIV-1 and clinical events, indicating both personal and public health benefits from such therapy. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 052 ClinicalTrials.gov number, NCT00074581.).
              Bookmark
              • Record: found
              • Abstract: not found
              • Article: not found

              Using Mixed-Methods Sequential Explanatory Design: From Theory to Practice

                Bookmark

                Author and article information

                Contributors
                Role: MethodologyRole: Project AdministrationRole: SupervisionRole: Writing – Original Draft PreparationRole: Writing – Review & Editing
                Role: Project AdministrationRole: SupervisionRole: Writing – Review & Editing
                Role: MethodologyRole: Project AdministrationRole: Writing – Review & Editing
                Role: Funding AcquisitionRole: MethodologyRole: SupervisionRole: Writing – Review & Editing
                Role: MethodologyRole: Project AdministrationRole: Writing – Review & Editing
                Role: InvestigationRole: MethodologyRole: Project AdministrationRole: Writing – Review & Editing
                Role: MethodologyRole: Project AdministrationRole: Writing – Review & Editing
                Role: Project AdministrationRole: SupervisionRole: Writing – Review & Editing
                Role: MethodologyRole: VisualizationRole: Writing – Review & Editing
                Role: Funding AcquisitionRole: InvestigationRole: MethodologyRole: SupervisionRole: Writing – Review & Editing
                Role: MethodologyRole: Project AdministrationRole: Writing – Review & Editing
                Role: Project AdministrationRole: SupervisionRole: Writing – Review & Editing
                Role: MethodologyRole: SupervisionRole: Writing – Review & Editing
                Role: Funding AcquisitionRole: InvestigationRole: Writing – Review & Editing
                Role: SupervisionRole: Writing – Review & Editing
                Role: InvestigationRole: SupervisionRole: Writing – Review & Editing
                Role: MethodologyRole: Writing – Review & Editing
                Role: MethodologyRole: SupervisionRole: Writing – Review & Editing
                Role: SupervisionRole: Writing – Review & Editing
                Role: MethodologyRole: SupervisionRole: Writing – Review & Editing
                Role: ConceptualizationRole: Funding AcquisitionRole: MethodologyRole: SupervisionRole: Writing – Review & Editing
                Role: ConceptualizationRole: MethodologyRole: SupervisionRole: Writing – Review & Editing
                Role: ConceptualizationRole: Funding AcquisitionRole: MethodologyRole: SupervisionRole: Writing – Review & Editing
                Role: ConceptualizationRole: Funding AcquisitionRole: MethodologyRole: Project AdministrationRole: SupervisionRole: Writing – Original Draft PreparationRole: Writing – Review & Editing
                Journal
                Wellcome Open Res
                Wellcome Open Res
                Wellcome Open Research
                F1000 Research Limited (London, UK )
                2398-502X
                7 November 2023
                2022
                : 7
                : 54
                Affiliations
                [1 ]Biomedical Research and Training Institute, Harare, Zimbabwe
                [2 ]MRC International Statistics & Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK
                [3 ]Department of Public Health, Environments and Society, London School of Hygiene & Tropical Medicine, London, UK
                [4 ]Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK
                [5 ]AIDS and TB Unit, Ministry of Health and Child Care, Harare, Zimbabwe
                [6 ]Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK
                [7 ]Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Munich, Germany
                [8 ]Ardent Creative, Harare, Zimbabwe
                [9 ]School of Public Health, University of Sydney, Sydney, Australia
                [10 ]National AIDS Council, Harare, Zimbabwe
                [11 ]Department of Population Health, London School of Hygiene & Tropical Medicine, London, UK
                [1 ]Department of Family Medicine, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa
                [1 ]Department of Family Medicine, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa
                London School of Hygiene & Tropical Medicine, UK
                [1 ]King's College Hospital NHS Foundation Trust, London, UK
                Author notes

                No competing interests were disclosed.

                Competing interests: No competing interests were disclosed.

                Competing interests: No competing interests were disclosed.

                Competing interests: No competing interests were disclosed.

                Competing interests: No competing interests were disclosed.

                Author information
                https://orcid.org/0000-0003-1617-3603
                https://orcid.org/0000-0003-0066-8345
                https://orcid.org/0000-0002-4897-458X
                https://orcid.org/0000-0002-9725-7931
                https://orcid.org/0000-0002-7042-2394
                https://orcid.org/0000-0003-3547-7936
                https://orcid.org/0000-0001-7628-8408
                https://orcid.org/0000-0001-6334-0318
                https://orcid.org/0000-0003-1693-5196
                https://orcid.org/0000-0002-9902-6248
                https://orcid.org/0000-0002-7660-9176
                Article
                10.12688/wellcomeopenres.17530.2
                10755263
                25ad3919-a344-40f3-9294-c68500bc5811
                Copyright: © 2023 Dziva Chikwari C et al.

                This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 25 October 2023
                Funding
                Funded by: Swiss Development Corporation
                Funded by: Medical Research Council
                Award ID: MR/T040327/1
                Funded by: Charlize Theron Africa Outreach Project (CTAOP)
                Funded by: Wellcome Trust
                Award ID: 206316
                The Trial is funded by the Wellcome Trust (Senior Fellowship to RAF: 206316/Z/17/Z). The nested STI trial is funded by the MRC/ESRC/DFID/NIHR (MR/T040327/1). The messaging component is funded by the Charlize Theron Africa Outreach Project (CTAOP). The menstrual management component was supported by the Swiss Development Corporation. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Study Protocol
                Articles

                hiv,youth,community,sexual and reproductive health,zimbabwe
                hiv, youth, community, sexual and reproductive health, zimbabwe

                Comments

                Comment on this article